Asthma in Children
Conditions
Brief summary
Asthma is the most common chronic disease of childhood and is a leading cause of emergency medical treatment. For children experiencing an asthma exacerbation, emergency department (ED) guidelines recommend early systemic corticosteroid (CS) administration, since studies have shown associated, time-sensitive, decreases in hospital admissions and ED length-of-stay (LOS). For patients who are treated by 911 emergency medical services (EMS) first, there exists an opportunity for even earlier administration of CS, prior to ED arrival. Yet, preliminary data demonstrate that currently less than 10% of EMS pediatric asthma patients receive CS prior to ED arrival. Given the known time-sensitivity of CS' effects on patient outcomes, the investigators hypothesize that even earlier EMS administration of CS will decrease hospital admissions, ED LOS, and intensive care unit admissions for pediatric patients with an acute asthma exacerbation. Using a pragmatic observation design in multiple EMS agencies, we will enroll patients to analyze clinical outcomes and comparative costs of EMS CS administration, and how both are influenced by EMS transport time. That novel combination of analyses will help build evidence-based guidelines adaptable for diverse EMS agencies nationwide.
Interventions
DRUGPrednisolone
During a sequenced rollout protocol change for several EMS agencies, those agencies will adopt protocol change to administer prednisolone to children with asthma attacks in the prehospital environment prior to ED arrival.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Florida
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* primary problem: Asthma exacerbation * stable to take an oral medication * transported by EMS to an ED
Exclusion criteria
* unconscious, hemodynamically unstable, or critically ill -\> EMS will proceed with usual critical care (includes IV methylprednisolone as per protocol) * daily or every other day corticosteroid therapy * allergy to prednisolone or another corticosteroid * chronic lung disease besides asthma, airway anatomic abnormalities, tracheostomy, immunocompromised, traumatic injury, pregnancy, law enforcement custody, non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Admission | Day 1 (ED stay) | Number of admissions to an inpatient unit (general or ICU) for an asthma exacerbation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emergency Department Length-of-stay | Day 1 (from EMS arrival to ED disposition) | Length of time in emergency department for patients from arrival to disposition (i.e., length of time for discharge, admission, or transfer to another hospital) |
Countries
United States
Participant flow
Recruitment details
There was no recruitment, as this was an observational study of patients who were receiving EMS treatment regardless of the study.
Pre-assignment details
EMS agencies who decided to incorporate oral systemic corticosteroids as part of clinical care were for this study. The study assigned the start date for EMS agencies to include oral systemic corticosteroids. For the purpose of analysis, we treated that as a stepped wedge protocol design. All agencies contributed one year of data for early prehospital systemic corticosteroids, and one year of data for no prehospital systemic corticosteroids.
Participants by arm
| Arm | Count |
|---|---|
| Early Prehospital Systemic Corticosteroids Children with asthma attacks who receive systemic corticosteroids in the prehospital environment by emergency medical services
Prednisolone: During a sequenced rollout protocol change for several EMS agencies, those agencies will adopt protocol change to administer prednisolone to children with asthma attacks in the prehospital environment prior to ED arrival. | 175 |
| Usual Care Children with asthma attacks treated by emergency medical services who receive usual care en route to emergency departments, where in the ED they then receive systemic corticosteroids | 659 |
| Total | 834 |
Baseline characteristics
| Characteristic | Early Prehospital Systemic Corticosteroids | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 8 years | 8 years | 8 years |
| Bronchodilator Administered | 159 Participants | 529 Participants | 688 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 107 Participants | 417 Participants | 524 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 29 Participants | 92 Participants | 121 Participants |
| Race (NIH/OMB) White | 37 Participants | 146 Participants | 183 Participants |
| Sex: Female, Male Female | 67 Participants | 381 Participants | 448 Participants |
| Sex: Female, Male Male | 108 Participants | 278 Participants | 386 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 175 | 0 / 659 |
| other Total, other adverse events | 0 / 175 | 0 / 659 |
| serious Total, serious adverse events | 0 / 175 | 0 / 659 |
Outcome results
Primary
Hospital Admission
Number of admissions to an inpatient unit (general or ICU) for an asthma exacerbation
Time frame: Day 1 (ED stay)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Early Prehospital Systemic Corticosteroids | Hospital Admission | 57 Participants |
| No Early Prehospital Systemic Corticosteroids | Hospital Admission | 208 Participants |
Secondary
Emergency Department Length-of-stay
Length of time in emergency department for patients from arrival to disposition (i.e., length of time for discharge, admission, or transfer to another hospital)
Time frame: Day 1 (from EMS arrival to ED disposition)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Early Prehospital Systemic Corticosteroids | Emergency Department Length-of-stay | 168 minutes |
| No Early Prehospital Systemic Corticosteroids | Emergency Department Length-of-stay | 159 minutes |